Monitoring patients with abdominal aortic aneurysms before and after surgery
Official title: Prospective Registry Study to Collect Imaging and Clinical Data on Patients With Aortic Aneurysm Disease Undergoing Serial Monitoring & Pre and Post Endovascular Repair
Run by ViTAA Medical Solutions · NCT05004051 · Data updated 2026-11-12
This study is trying to see how well a new imaging technology works for monitoring patients with abdominal aortic aneurysms before and after they have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | ViTAA Medical Solutions Industry-sponsored |
| Locations | 8 sites (Birmingham, Alabama and 7 other locations) |
| Status | Recruiting |
| Started | December 15, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 19, 2025 |
| Trial ID | NCT05004051 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with infrarenal aortic aneurysms measuring 45 mm or more in diameter.
✕Probably not a fit
Patients with major connective tissue disorders, renal failure, or previous aortic reconstruction in the involved segment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry collects imaging and clinical data from patients with abdominal aortic aneurysms undergoing endovascular repair and those in a serial monitoring program. The study utilizes ViTAA aortic mapping technology to assess patients at multiple centers across the US and Canada. Participants include those scheduled for endovascular repair and those who do not yet meet the criteria for surgery but require ongoing monitoring.
Why it matters
Potential benefit: If successful, this study could enhance the management and outcomes of patients with abdominal aortic aneurysms through improved monitoring techniques.
How similar studies have gone: Other studies utilizing registry approaches for monitoring aortic aneurysms have shown promise, indicating potential for success in this study as well.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient is aged 18 years or over 2. Infrarenal Aortic Aneurysm ≥ 45 mm in diameter. 3. Patient meets on-IFU criteria for endovascular reconstruction Exclusion Criteria: 1. Patient has a known or clinically suspected major connective tissue disorder, autoimmune disorder, vasculitis, or aortic dissection. 2. Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.0mg/dL or 175umol/L 3. Patients with previous aortic reconstruction in the involved segment. 4. Patients receiving oral or parenteral corticosteroid therapy for other unrelated disease. (Excludes inhaled corticosteroids). 5. Patient has a sensitivity to contrast imaging agents. 6. Patient has aortic dissection. 7. Patient has atrial fibrillation. 8. Patient has arrhythmia.
Where it's running
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UAB - University of Alabama in Birmingham Hospital
Birmingham, Alabama, United States Recruiting -
MGH - Massachusetts General Hospital Fireman Vascular Center
Boston, Massachusetts, United States Recruiting -
UNC - University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States Recruiting -
University of Washington
Seattle, Washington, United States Recruiting -
UCGY - University of Calgary, Peter Lougheed Center
Calgary, Alberta, Canada Recruiting -
UHN - University Health Network - Toronto General Hospital
Toronto, Ontario, Canada Recruiting
Show 2 more locations
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CHUM - Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada Recruiting -
MUHC - McGill University Health Centre
Montreal, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Mark Farber — University of North Carolina, Chapel Hill
- Study coordinator: Denis Bilodeau
- Email: denisbilodeau@vitaamedical.com
- Phone: 5145728673
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Physician-modified endograft repair for complex abdominal and thoracoabdominal aortic aneurysms in high-risk patients
This study will try physician-modified endografts to repair complex abdominal and thoracoabdominal aortic aneurysms in patients who are too high-risk for open surgery and do not meet criteria for currently approved devices.
-
Using modified endovascular grafts to treat abdominal aortic aneurysms
This study is testing a new type of graft to see if it can safely and effectively treat abdominal aortic aneurysms in patients who can’t have regular surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.